Ag Telmisartan-HCT: Uses, Side Effects and Dosage

What is AG Telmisartan-HCT used for?

• AG Telmisartan-HCT is used in adults to lower high blood pressure.

How does AG Telmisartan-HCT work?

AG Telmisartan-HCT contains a combination of 2 drugs, telmisartan and hydrochlorothiazide:

• Telmisartan is an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. It works by blocking a substance in the body that causes blood vessels to tighten. It helps lower blood pressure.
• Hydrochlorothiazide is a diuretic or “water pill” that increases urination. It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. It also helps lower blood pressure.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking AG Telmisartan-HCT regularly even if you feel fine. Do not stop taking your medicine without talking to your healthcare professional.

What are the ingredients in AG Telmisartan-HCT?

Medicinal ingredients: Telmisartan and hydrochlorothiazide

Non-medicinal ingredients: Hypromellose, iron oxide red (for 80 / 12.5 mg tablet only), iron oxide yellow (for 80 / 25 mg tablet only), lactose monohydrate, mannitol, meglumine, povidone, purified water, sodium hydroxide, and sodium stearyl fumarate.

AG Telmisartan-HCT comes in the following dosage forms:

Tablets: 80 mg / 12.5 mg and 80 mg / 25 mg

Do not use AG Telmisartan-HCT if:

• you are allergic to telmisartan, hydrochlorothiazide or to any non-medicinal ingredient in AG Telmisartan-HCT (see What are the ingredients in AG Telmisartan-HCT?).

• you are allergic to any sulfonamide-derived drugs (sulfa drugs), most of them have a

  medicinal ingredient that ends in “-MIDE”. This includes other diuretics (“water pills”).

• you have experienced an allergic reaction (angioedema) with swelling of the hands, feet or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing to any ARB (any drug in the same class as AG Telmisartan-HCT). Be sure to tell your healthcare professional that this has happened to you.
• you have difficulty urinating or produce no urine.

• you are pregnant or planning to become pregnant. Taking AG Telmisartan-HCT during pregnancy can cause injury and even death to your baby.

• you are breastfeeding. AG Telmisartan-HCT passes into breast milk.
• you are allergic to some sugars (fructose, lactose and / or sorbitol).
• you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder where you cannot break down fructose. AG Telmisartan-HCT 80 mg / 12.5 mg and 80 mg / 25 mg tablets contain 338 mg of a similar type of sugar called sorbitol.
• you are already taking a blood pressure-lowering medicine that contains aliskiren and you have diabetes or kidney problems.

• you have one of the following rare hereditary diseases:

  • Galactose intolerance;
  • Lapp lactase deficiency;
  • Glucose-galactose malabsorption.

This is because lactose is a non-medicinal ingredient in AG Telmisartan-HCT.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG Telmisartan-HCT. Talk about any health conditions or problems you may have, including if you:

• have a history of allergic reactions (angioedema).
• are allergic to penicillin.
• have narrowing of an artery or a heart valve.
• have heart failure.
• have diabetes. AG Telmisartan-HCT may cause low blood sugar levels.
• have liver or kidney problems.

• are taking any of the following:

  • blood pressure-lowering medicines, such as aliskiren
  • an angiotensin-converting enzyme inhibitor (ACEI)
  • beta blockers (i.e., acebutolol, metoprolol). Do NOT stop taking your beta blocker without talking to your healthcare professional as this can cause serious side effects.
  • have lupus, an autoimmune disease that can affect many parts of the body.
  • have gout, a type of arthritis.
  • are on dialysis.
  • are dehydrated or if you suffer from excessive vomiting, diarrhea, or sweating.
  • are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill” that makes your body keep potassium).
  • are on a low-salt diet.
  • are less than 18 years old.
  • have been told by your healthcare professional that you have an intolerance to some sugars.
  • have had skin cancer or have a family history of skin cancer.
  • are taking a medicine that contains lithium. The combination with AG Telmisartan-HCT is not recommended.
  • have a greater chance of developing skin cancer because you have light-coloured skin, get sunburned easily, or are taking medicines to suppress your immune system.

Other warnings you should know about: Risk of skin cancer:

• AG Telmisartan-HCT contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking AG Telmisartan-HCT for many years (more than 3) or at a high dose.
• While taking AG Telmisartan-HCT:
• Make sure to regularly check your skin for any new lesions. Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back.
• Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.

Talk to your healthcare professional immediately if you become more sensitive to the sun or UV light or if you develop an unexpected skin lesion (such as a lump, bump, sore, or patch) while you are taking AG Telmisartan-HCT.

Increased sensitivity of the skin to sun: Your skin may become sensitive to the sun while taking AG Telmisartan-HCT. Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.

Surgery: Before surgery and general anesthesia (even at the dentist’s office), tell the healthcare professional that you are taking AG Telmisartan-HCT, as there may be a sudden fall in blood pressure associated with general anesthesia.

Allergic Reactions / Angioedema: Allergic reactions (angioedema) causing swelling of tissues under the skin, sometimes affecting the face and throat, have happened in people taking AG Telmisartan-HCT. These allergic reactions may happen at any time during treatment with AG Telmisartan-HCT and can be life-threatening. Very rarely, cases have been fatal. If you experience an allergic reaction, stop taking AG Telmisartan-HCT and get immediate medical help.

Blood Tests: AG Telmisartan-HCT can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Driving and using machines: Before you perform tasks, which may require special attention, wait until you know how you respond to AG Telmisartan-HCT. Dizziness, lightheadedness, sensation that you, or the environment around you, is moving or spinning (vertigo) or fainting can occur, especially after the first dose and when the dose is increased.

If patients experience these adverse events, they should avoid potentially hazardous tasks such as driving or operating machinery.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious Drug Interactions

Do not take AG Telmisartan-HCT with other blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products, or angiotensin-converting enzyme inhibitors (ACEI) if you have diabetes (type 1 or type 2) or serious kidney problems. When taken together with AG Telmisartan-HCT, they may cause very low blood pressure.

The following may interact with AG Telmisartan-HCT:

• adrenocorticotropic hormone (ACTH) used to treat West Syndrome
• alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.
• amphotericin B, an antifungal drug
• anticancer drugs, including cyclophosphamide and methotrexate
• antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline
• antidiabetic drugs, including insulin and oral medicines, such as repaglinide
• beta blockers, medications for heart problems
• bile acid resins used to lower cholesterol, such as cholestyramine and colestipol resins
• calcium or vitamin D supplements
• corticosteroids used to treat joint pain and swelling
• digoxin, a heart medication
• drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone
• drugs used to treat epilepsy, including carbamazepine and topiramate
• gout medications, including allopurinol and probenecid
• lithium used to treat bipolar disease
• nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling (such as ibuprofen, naproxen, and celecoxib)

• medicines that increase the levels of potassium in your blood. These include:

  • potassium-sparing diuretics,
  • potassium supplements or
  • potassium-containing salt substitutes.
• pressor amines, such as norepinephrine
• skeletal muscle relaxants used to relieve muscle spasms, including tubocurare
• warfarin used to thin the blood to prevent blood clots

How to take AG Telmisartan-HCT:

• AG Telmisartan-HCT is not for initial therapy. You must first be stabilized on the individual components of AG Telmisartan-HCT (i.e., telmisartan and hydrochlorothiazide).
• Take AG Telmisartan-HCT exactly as prescribed. It is recommended to take your dose at about the same time every day preferably in the morning.

• AG Telmisartan-HCT can be taken with or without food, but it should be taken the same way each day.

• AG Telmisartan-HCT tablets are for once-daily oral administration and should be swallowed whole with liquid.
• If AG Telmisartan-HCT causes upset stomach, take it with food or milk.

Usual dose:

Adults: One tablet daily.

Overdose:

If you think you, or a person you are caring for, have taken too much AG Telmisartan-HCT, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

What are possible side effects from using AG Telmisartan-HCT?

These are not all the possible side effects you may have when taking AG Telmisartan-HCT. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Back or leg pain, muscle cramps, joint pain, muscle spasms, pain, weakness, restlessness;
• Headache, anxiety, dizziness, pins and needles in your fingers;
• Diarrhea, constipation, nausea, vomiting, upset stomach, abdominal pain, flatulence, decreased appetite, enlargement of the glands in your mouth;
• Dry mouth;
• Rash, eczema, skin eruptions, bleeding under the skin, red patches on the skin;
• Drowsiness, insomnia, fatigue;
• Upper respiratory infection;
• Reduced libido.
• Very rare: Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past or if you develop any severe shortness of breath or difficulty breathing after taking AG Telmisartan-HCT, seek medical attention immediately.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature 15-30^oC in the packaging provided by your healthcare professional and protect from excessive moisture. Due to the way the tablets are made, they should be taken out of the sealed blister shortly before being taken.

Keep out of reach and sight of children.

If you want more information about AG Telmisartan-HCT :

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), or by calling 1-450-449-9272.